Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatment lifestyle counseling
Sponsor The Miriam Hospital
Start date November 2012
End date April 2016
Trial size 250 participants
Trial identifier NCT01724632, 1R01DK095779

Summary

The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants will be weighed individually at the start of each group meeting.
lifestyle counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.
(Active Comparator)
Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.
lifestyle counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.
(Experimental)
Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months.
lifestyle counseling
Participants receive instructions for making healthy changes to their diet and physical activity habits.

Primary Outcomes

Measure
Weight Loss
time frame: Change from baseline to 18-months.

Secondary Outcomes

Measure
Weight-related Behaviors
time frame: Change from baseline to 18-months.

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Body Mass Index (kg/m2) of 25-45. - English language fluency - Ability to read at a 6th grade level - Availability to attend weekly treatment sessions in Providence, RI Exclusion Criteria: - Any heart condition that limits ability to participate in physical activity - Chest Pain - Any cognitive of physical limitation that would preclude use of a smartphone - Serious mental illness - Historical or current eating disorder - Previous or planned bariatric surgery - Use of weight loss medication - Recent pregnancy or a plan to become pregnant in the next 6 months - Participation in a study at the Weight Control and Diabetes Research Center within the last two years - A weight loss of greater than 5% body weight in the last 6 months

Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by The Miriam Hospital.